national accreditation focal points accreditation focal points ... accreditation bodies nabcb and...

TECHNICALCOOPERATION

Physikalisch-Technische BundesanstaltBraunschweig und BerlinNationales Metrologieinstitut

Manfred Kindler, Uwe Miesner

National Accreditation Focal Points A collaborative approach to develop national accreditation services

List of abbreviations 2

Introduction 3

Part I Basic concept and principles of a National Accreditation Focal Point 4

1. What is a National Accreditation Focal Point? 4

2. Advantages and challenges of developing a National Accreditation Focal Point 6

3. Types and key characteristics of a National Accreditation Focal Point 8

4. Division of tasks between NAFP and Partner AB and compatibility with IAF / ILAC rules 12

Part II Guideline for the establishment of a National Accreditation Focal Point 15

5. The components of a National Accreditation Focal Point 15

6. Competence of NAFP staff: Recommendations on human resource development 18

7. The roadmap to establish a National Accreditation Focal Point 19

8. Conclusions and outlook 23

Annex

1. Memorandum of Understanding between an NAFP and a Partner Accreditation Body (draft model) 24

2. Lead questions for self-assessment 26

CO N T E N T S

List of abbreviations

AB Accreditation BodyAAPG Accreditation Auditing Practices GroupAPG Auditing Practices GroupAPLAC Asia-Pacific Laboratory Accreditation CooperationCAB Conformity Assessment BodyCARICOM Caribbean CommunityEA European Cooperation for AccreditationEAAB East African Accreditation BoardECA Ente Costarricense de AcreditaciónIAAC Inter-American Accreditation CooperationIAF International Accreditation ForumIEC International Electrotechnical CommissionILAC International Laboratory Accreditation CooperationISO International Organization for StandardizationJANAAC Jamaica National Agency for AccreditationMLA Multilateral Recognition AgreementMoU Memorandum of UnderstandingMRA Mutual Recognition ArrangementNABCB National Accreditation Board for Certification BodiesNABL National Accreditation Board for Testing and Calibration LaboratoriesNAFP National Accreditation Focal PointNBSM Nepal Bureau of Standards and MetrologyPAC Pacific Accreditation CooperationPAB Partner Accreditation BodyPTB Physikalisch-Technische BundesanstaltQI Quality InfrastructureSADCAS Southern African Development Community Accreditation ServiceTTLABS Trinidad & Tobago Laboratory Accreditation Service

L I S T O F A B B R E v I AT I O N S

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Introduction

In an increasingly globalized market place, accessible and internationally recognized accreditation services have be-come a prerequisite for trade and economic develop-ment. However, not every country can afford to establish and sustain a full-fledged and internationally recognized accreditation body. This is particularly true for small eco-nomies with a limited number of laboratories and other conformity assessment bodies. Similarly, it is foreseeable that even larger economies may not be able to cover every accreditation area to an adequate degree.

In those cases, a collaboration between internationally recognized national accreditation bodies and emerging local accreditation service providers could help to satisfy customer demands for accepted accreditation services while saving scarce financial and human resources. A pos-sible approach is the establishment of a National Accred-itation Focal Point (NAFP). The NAFP concept is currently applied in different regions of the world and is also act-ively promoted in some projects of PTB’s International Technical Cooperation.

Drawing from PTB’s experience in supporting the setting up of NAFPs world-wide, this paper presents main types and characteristics of this concept. Besides, it illustrates practical implementation steps and lessons learned gained from technical cooperation of PTB. Its ultimate objective is to assist political decision makers and institu-tions of the national quality infrastructure1 in their en-deavour to build up accreditation capacities in their coun-try using an NAFP.

1 The term “quality infrastructure” comprises metrology, standardization, testing, certification, inspection and accreditation.

The paper is divided into two parts: Part I provides an in-troduction into the basic concept and underlying ra-tionale of an NAFP. Part II is designed as a more technical guideline on the establishment of an NAFP.

Finally, the authors would like to thank all those experts who provided valuable input and feedback to this paper. Our special thanks go to Mr Hanspeter Ischi, former Head of the Swiss Accreditation Service, Mr Pasquale Paladino, former Director Conformity Assessment of the Standards Council of Canada and Dr Joachim Thiele, Federal Insti-tute for Materials Research and Testing, Section „Accred-itation and Conformity Assessment“, Germany.

I N T R O D U C T I O N

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Laboratories Certification Bodies Inspection Bodies

Agreement

Application Recognition

Assessment/ Accreditation

International Best Practice

Division of tasks

Partner Accreditation

Body

National Accreditation

Focal Point

Part I – Basic concept and principles of a National Accreditation Focal Point

Regardless of its exact shape, a common characteristic of an NAFP is its close collaboration with a foreign National Accreditation Body – hereafter called “Partner Accredita-tion Body” (Partner AB) – which enjoys international re-cognition through its membership in mutual recognition arrangements of the international accreditation net-works2. The Partner AB provides its technical competence for assessing conformity assessment bodies and is ulti-mately responsible for providing the official international accreditation certificate. Therefore, establishing a close and trustful collaboration between the NAFP and its Partner AB is the cornerstone of an effective implement-ation of the NAFP concept (see figure 1).

2 International Laboratory Accreditation Cooperation (ILAC): http://www.ilac.org and International Accreditation Forum (IAF): http://www.iaf.nu

1. What is a National Accreditation Focal Point?

National Accreditation Focal Points (NAFPs) have be-come a wide spread tool in regional cooperation com-munities to establish national accreditation systems or to coordinate accreditation activities with internationally re-cognised accreditation bodies in a structured manner. However, despite their increasing popularity, there is no universally accepted definition of what an NAFP exactly is. Instead, an NAFP is defined by its core function, which is: To make an internationally recognized accreditation for laboratories, certification and inspection bodies available in partnership with a recognized foreign accreditation body.

To fulfil this function, an NAFP acts as the national ad-ministrative link between potential clients and estab-lished accreditation bodies and is usually responsible for the administration, coordination and marketing of ac-creditation services. However, it may vary significantly in type, scope of activities and technical expertise, ranging from a formal, administrative contact point to an inde-pendent NAFP Office with substantial technical in-house expertise (see chapter 3).

Fig. 1: National Accreditation Focal Point Concept – Basic elements

PA R T I – B A S I C C O N C E P T A N D P R I N C I P L E S O F A N AT I O N A L A C C R E D I TAT I O N F O C A L P O I N T

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In principle, the NAFP concept can be applied both on bi-lateral as well as on regional basis. In practice, it is pre-dominantly applied in regional integration schemes that aim to reduce technical barriers to trade through recog-nized conformity assessments. In this context, the usually existing heterogeneity of member states presents an ac-tual opportunity to share facilities and foster partnerships among national accreditation systems. These partner-ships may also include more than one Partner AB, espe-cially where the accreditation scope of this organization is limited to laboratory or certification body accreditation only.

Historically, the first Focal Points were established in 2003 in the Southern African Development Community where they became an integral part of a regional accred-itation body (SADCAS) later on3. In the Caribbean region, NAFPs were set up with close links to the National Ac-creditation Bodies in Jamaica (JANAAC) and Trinidad & Tobago (TTLABS), while in Central America, Honduras is cooperating with the Partner AB ECA in Costa Rica. In the East African Community, Uganda established the first NAFP of the regional East African Accreditation Board (EAAB) in 2010.

3 In the case of SADCAS, NAFPs are part of a regional accreditation system which does not include any Partner AB.

Finally, a trend towards establishing NAFPs can also be observed in Asia. In South Asia, Bhutan concluded a Memorandum of Understanding (MoU) with the Indian accreditation bodies NABCB and NABL in 2012, while NBSM Nepal and NABCB India signed a MoU in 2014. Within ASEAN, Cambodia, Laos and Myanmar are in the process of initiating cooperation agreements with poten-tial Partner ABs in the region.

As an example, a draft proposal for a MoU between an NAFP and a Partner AB is provided in annex 1.

Fig. 2: Regional Economic Communities with National Accreditation Focal Points in Africa

EAC

SADC


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2. Advantages and challenges of developing a National Accreditation Focal Point

Formally speaking, the cooperation between an NAFP and a Partner AB can be regarded as a type of cross fron-tier accreditation which complies with the respective ILAC principles for cooperation (see box 1). Still, the NAFP concept goes beyond these principles as it is based on a formalized, mid- or long-term partnership which aims to gradually enhance the capacities of the domestic accreditation service. Thus, a coordinated approach to meet accreditation demands of domestic customers is not a case-specific by-product but rather the intended outcome of a joint decision on strategic collaboration that offers advantages for both, the host country of the NAFP and the Partner AB.

Box 1: ILAC-G21:09/2012 Cross Frontier Accreditation – Principles for Cooperation

3. Cooperation with the domestic accreditation body3.2 When an accreditation body that is a signatory to the ILAC Arrangement decides to provide accredita-tion services outside its country (economy), it should ensure that appropriate assessors are used, taking into account factors such as language, local laws and regu-lations, culture, etc., as well as technical competence requirements. The foreign accreditation body should also consult the domestic accreditation body and take into consideration any relevant accreditation require-ments that the domestic accreditation body has set to suit the local conditions.

3.3 The preferred ILAC approach to ensure access to relevant competence is to cooperate to the greatest extent practicable with the domestic accreditation body by using its personnel, as appropriate, on the assessment team.

3.4 If it is not possible to include personnel from the domestic accreditation body on the assessment team, cooperation with the domestic accreditation body should be extended to invite the domestic accredit-ation body to observe the assessment, subject to ac-ceptance by the applicant.

3.5 Where the domestic accreditation body is not a sig-natory to the ILAC Arrangement, or where the scope of the domestic accreditation body does not cover the re-quested activity, the foreign accreditation body should try to cooperate with the domestic accreditation body according to these principles so as to provide the do-mestic accreditation body with the opportunity to gain experience to apply for the ILAC Arrangement.


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From the host country’s perspective, an NAFP represents an economically viable concept to introduce and dissem-inate accreditation services without necessarily investing time and resources in establishing a full-fledged National Accreditation Body. Moreover, the close collaboration with a recognized foreign accreditation body helps to transfer knowledge and to gradually develop capacities in accreditation, thus, reducing the dependence on external and expensive consultancy services. Once these capacit-ies will be developed to an adequate extent, they may also be used to technically underpin national registration or notification processes which involve an assessment of conformity assessment bodies.

From the customer’s perspective, i.e. laboratories, certi-fication and inspection bodies, an NAFP ensures that in-ternationally recognized accreditation services are easily accessible within the domestic market. Additionally, NAFPs reduce transaction costs as information and ad-ministrative support services are locally available. Geo-graphical proximity between the NAFP and local industry may also help to jointly raise awareness of and lobby for transparent and recognized conformity assessment ser-vices.

From the foreign Partner AB’s perspective, collaboration with an NAFP facilitates the outreach and management of accreditation services in markets that may otherwise be difficult to serve. This applies in particular in those cases where accreditation, licensing or registration is reg-ulated by national authorities so that it is impossible for foreign ABs to grant accreditation in those countries without any specific agreement with the responsible au-thority. Besides, a gradually evolving NAFP may help to expand the expert and assessor pool of the Partner AB which ultimately may also be employed in the domestic market of the Partner AB. From a broader perspective, a Partner AB also contributes to reducing technical barriers to trade, thus increasing its reputation as a centre of ex-pertise within regional integration schemes.

However, besides these advantages, the implementation of an NAFP bears challenges as well. These challenges can arise on the side of the NAFP, the Partner AB or may originate from external influences.

The NAFP may experience ambiguous or even missing coordination by involved ministries or responsible au-thorities. An insufficient understanding on roles and re-sponsibilities or a lack of clear structures and communic-ation between the NAFP and the Partner AB can further aggravate the development and functioning of the NAFP. Differing interests and/or non-compliance with IAF/ILAC guidelines for cross frontier accreditation (see chapter 4) may hamper the cooperation to work effect-ively.

Another challenge can be insufficient market demand to maintain an NAFP. Certification, inspection, calibration or testing services may be inadequately required to justify the establishment of the NAFP. Poor cost recovery (budget bottlenecks, financial crisis, market conditions) may affect the NAFP once it has been established. Ex-pectations on the levels of fees or financial compensation may also differ between the NAFP and the Partner AB and should be clarified at the very beginning.

Last, leadership competencies and personnel manage-ment (team leader, NAFP manager, responsible person of the Partner AB) need to be efficient and stable. Fluctuat-ing staff of the NAFP or of the Partner AB can endanger the success of the model. The work load can be high and should thus be regulated to an acceptable amount.


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3. Types and key characteristics of a National Accreditation Focal Point

In a simplified manner, the involvement of an NAFP in the accreditation process and its interaction with poten-tial customers and the Partner AB follows a three-step procedure: The NAFP receives an accreditation request from a domestic conformity assessment body (CAB). The request is handled by the NAFP and transmitted to the Partner AB. The Partner AB undertakes an assessment of the CAB and – if successful – grants (internationally re-cognized) accreditation. Besides its involvement in the accreditation procedure itself, the NAFP may be assigned other responsibilities such as raising awareness for ac-creditation or organizing training programs for laboratory staff and potential auditors and assessors, often in direct collaboration with the Partner AB.

The actual responsibilities and level of involvement of the NAFP in the accreditation process depend on the agreed division of tasks and available in-house expertise. Here, we define five different levels of involvement. The higher the level, the more activities an NAFP takes over and the more it increases its influence in the accreditation pro-cess.

■■ Level 1: Formal contact point, ■■ Level 2: Competent contact person, ■■ Level 3: Qualified NAFP Manager who is supported

by national experts, ■■ Level 4: NAFP Office which is involved in joint as-

sessments, ■■ Level 5: Independent NAFP Office which participates

in joint accreditations.

The levels describe development stages from the starting point up to an independent NAFP Office. Therefore, the creation of an NAFP could be considered the first step in becoming a National Accreditation Body, underlining the transitional nature that is characteristic for many NAFPs. However, it should be noted that each level represents a cooperation model that could be established in its own right. This means that an NAFP that aims, for instance, at level 3 neither necessarily has to undergo level 1or 2 be-fore, nor subsequently has to strive for level 4 and 54.

In any case, each level has its distinct features with regard to the institutional set-up and division of tasks between the NAFP and the Partner AB. Accordingly, the required competences and the degree of interaction with the Part-ner AB differs significantly. Each level is briefly described below:

4 This approach applies, e.g. in the case of the Caribbean region where the Caribbean Cooperation for Accreditation (CCA) is currently being established. Here, several member countries opt for intermediate levels (such as level 3) as the final development stage of their NAFP, so capacity building focuses directly on achieving that level.

Fig. 3: Core steps of accreditation procedure with NAFP involvement

Conformity Assessment Body

Conformity Assessment Body

National Accreditation Focal Point

Partner Accreditation Body

Submits application for Accreditation

Formally checks and forwards application

Assesses competence of CAB and issues accreditation


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Level 1: Formal Contact Point

Key characteristicFormal contact point that just provides administrative support to the accreditation process, no qualified staff available/required

Institutional set-upFully integrated into a ministry, an institution of the qual-ity infrastructure or another suitable institution (“parent organisation” in terms of ILAC or IAF)

Tasks and responsibilitiesReceives accreditation requests, provides information material, informs Partner AB, participates in ceremony (handover of certificate)

Required competences and resourcesNo specific knowledge and experiences required

RemarksThe involved persons at the contact point have to sign a confidentiality commitment and have to establish a qual-ity procedure for handling requests.

Level 2: Competent Contact Person

Key characteristicContact point with a certain degree of technical compet-ence that handles selected tasks of the application and accreditation procedure

Institutional set-upFully integrated into a ministry, an institution of the qual-ity infrastructure or another suitable institution (“parent organisation” in terms of ILAC or IAF)

Tasks and responsibilitiesSee level 1, plus: coordinates application and accredita-tion procedures in cooperation with the Partner AB

Required competences and resourcesContact person familiar with accreditation procedures and relevant standards, knows the case manager and other responsible persons of the Partner AB

Remarks The difference to level 1 is: The contact person has been introduced to the Partner AB, gained some practical in-sights and knowledge, and handles selected parts of the application procedure.


request assessment/ accreditation

information

Partner Accreditation

Body

QI Institution

NAFP


request assessment/ accreditation

selected involvement

introduction Partner Accreditation

Body

QI Institution

NAFP

Fig. 4: Level 1 NAFP Fig. 5: Level 2 NAFP


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Level 3: Qualified NAFP Manager

Key characteristicA well-trained full-time NAFP Manager supports the ac-creditation procedures of the Partner AB. National ex-perts listed in a database, participate as observers and/or technical experts. Qualification as assessors is in process.

Institutional set-upIntegrated into a QI institution with use of external ex-perts

Tasks and responsibilitiesSee level 2, plus: Coordinates pool of national experts; participates in regular meetings with the Partner AB for exchange of experiences and updating.

Required competences and resourcesManager familiar with accreditation procedures and rel-evant standards (see chapter 6); pool of trained technical experts

RemarksDifference to level 2: A well-trained full-time NAFP man-ager serves the clients and is responsible for identifying individuals and centres of national expertise. A pool of ex-perts that meet the demanded qualification and experi-ence criteria will be established.

Level 4: NAFP Office (Joint Assessment)

Key characteristicWell-trained NAFP Manager of the NAFP Office particip-ates actively with NAFP experts in accreditation activities of the Partner AB, including joint assessments

Institutional set-upConnected to a QI institution with a certain degree of in-dependence (e.g. own budget)

Tasks and responsibilitiesSee level 3, plus: Cooperation in joint assessments, in-cluding (partial) involvement in:■■ Pre-evaluation of application documents■■ Selection of experts for the assessment team■■ Document review with national experts■■ On-site assessment with national experts■■ Participation in surveillance visits

Required competences and resourcesOffice staff familiar with accreditation procedures and relevant standards; pool of fully trained experts as tech-nical assessors

RemarksThe difference to level 3 is the joint assessment service. However, the Partner AB is always fully responsible for the decision-finding procedures. The NAFP manager or the national experts are trained, qualified and recognized as assessors by the Partner AB.


subcontracted activities

assessment/ accreditation


training participation Partner

Accreditation Body

QI Institution

NAFP+ external

expert pool



(joint)assessment



Accreditation Body

QI Institution

Fig. 6: Level 3 NAFP Fig. 7: Level 4 NAFP

request request

NAFP+ external

expert pool


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Level 5: Independent NAFP Office (Joint Accreditation)

Key characteristicThe NAFP operates like a National Accreditation Body and issues accreditation certificates which are recognized by national authorities (licensing, registration, authoriza-tion, etc). Technical sector committees and advisory board are established.

Institutional set-upFully independent NAFP Office, i.e. self-financed or gov-ernmental / donor sponsoring for start-up phase

Tasks and responsibilitiesSee level 4, plus: NAFP Office covers important parts of the accreditation process of the Partner AB (Joint Accred-itation)

Required competences and resourcesNAFP should meet ISO/IEC 17011 requirements

RemarksNAFP with external assessor pool now collects the re-quired experience in accreditation for the MRA/MLA membership in ILAC/IAF and regional organizations

Once the level 5 has been reached, the NAFP is ready to be designated as National Accreditation Body (NAB) and to apply for a Pre-Peer Evaluation. Provided that the NAB successfully passes this evaluation for a certain area, it qualifies as IAF/ILAC recognized NAB for a specific scope. Finally, if it extends the MRA to all areas, it has reached the status of an IAF/ILAC recognized NAB for all scopes.


subcon-tracted

activities

(joint)accreditation



Accreditation Body

QI Institution

NAFP+ external

expert pool

Fig. 8: Level 5 NAFP

request


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4. Division of tasks between NAFP and Partner AB and compatibility with IAF / ILAC rules

As described above, the scope of responsibilities handled by the NAFP gradually increases with each level. From level 4, the NAFP is fully involved in nearly all aspects of the accreditation procedure. In other words: The Partner AB can subcontract all activities to the NAFP, except the decision-making. The Partner AB must retain full re-sponsibility for this activity to ensure international recog-nition of the accreditation.

The division of tasks between NAFP and Partner AB is il-lustrated in figure 9. The procedure for accreditation is di-vided into 13 steps plus management of complaints and appeals. The boxes marked with x represent the full parti-cipation of the NAFP, the ones marked with (x) indicate partial involvement. As illustrated below, handling of re-quests (# 1) and participation in the official hand-over ce-remony of the accreditation certificate (# 11) are the only steps in which the NAFP is (partly) involved from the very beginning.

NAFP Level 1 Level 2 Level 3 Level 4 Level 5

# Process NAFP PAB NAFP PAB NAFP PAB NAFP PAB NAFP PAB

1 Handling request x x x (x) x (x) x x

2Handling application

x x x x x x x x x

3Check of application

x x x x x x x

4Selection of Assessors

x x (x) x x x x x

5 Document review x x (x) x x x x x

6Corrective actions Document review

x x (x) x x x x x

7 On-site assessment x x (x) x x x x x

8Corrective actions On-site assessment

x x (x) x x x x x

9 Reporting x x (x) x x x x x

10 Decision finding x x x x (x) x

11 Ceremony (x) x x x x x x x x x

12 Surveillance x x (x) x x x x x

13 Re-Accreditation x x (x) x x x x x

14Complaint Management

x x (x) x x x x x

Fig. 9: Accreditation procedure and division of tasks


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At level 5, the procedure of decision finding is as follows: The Partner AB decides about the issuing of an IAF / ILAC recognized accreditation certificate, while the NAFP is responsible for the decision finding in the mandatory area of the country, based on the national legislation. For example, it decides on the fitness of a laboratory for the authorization by the responsible national ministry. In case of a positive decision of both the Partner AB and the NAFP, the laboratory will get at least two certificates: one from the Partner AB about international recognition and another one from the NAFP and the related Ministry about the national authorization in the mandatory area.

Particularly from the Partner ABs perspective, the division of work with the NAFP leads to the question of how to ensure that the institutionalized partnership is compat-ible with IAF / ILAC rules. In this respect, one of the main principles of the NAFP concept states that the coopera-tion should never jeopardize the international recognition of the partner accreditation body. Therefore, activities carried out under the cooperation must meet the scrutiny of a peer evaluation through which the equivalence of the Partner ABs accreditation program is recognized under the IAF Multilateral Recognition Arrangement and ILAC Mutual Recognition Arrangement, respectively.

Within the scope of this paper, three aspects should be highlighted: Responsibility of decision taking, transpar-ency on international activities and access to expertise.

Responsibility of decision-takingAccording to IAF / ILAC requirements, accreditation de-cisions shall not be subject to external influence or ap-proval (see box 2). Consequently, from level 1 up to level 5 the NAFP has no decision-taking power for granting ac-creditation to CABs that are seeking international recog-nition. Instead, a Level 5 NAFP may only decide about the national recognition of a CAB in the mandatory area, based on the authorization through the responsible min-istry. In any case, for the international market the Partner AB always signs internationally recognizable certificates of accreditation to CABs.

Transparency on international activitiesIn the peer evaluation process, the AB under evaluation is required to present information, facts and figures about its performance and operations. This includes informa-tion on its accreditation activities outside of its own ter-ritory and a description of its cross frontier policy (see box 3). Accordingly, the cooperation with the NAFP needs to be reflected on in this context.

Box 2: IAF/ILAC A5:07/2012 IAF/ILAC MLA/MRA: Application of ISO/IEC 17011:20044.2 StructureM. 4.2.2.1: Accreditation decisions shall not be sub-ject to approval by any other organisation or person.

Box 3: IAF/ILAC-A3:01/2013 IAF/ILAC Arrange-ments: Narrative Framework for Reporting on the Performance of an AB – A Tool for the Evaluation Process4.6 Accreditation Activity4.6.1/4.6.2 Normative documents, application and guidance documentsThe information provided by the AB shall contain (but should not be limited to) the following:- (...)- Any economies outside of their own in which the AB provides accreditation and the number of the respective accreditations. A description of the ABs cross frontier accreditation policy shall be provided.


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Access to expertiseThe AB which is subject to a peer evaluation has to en-sure the competence of its personnel. Consequently, NAFP staff that is involved in the accreditation process needs to participate in trainings, assessor exchange of ex-perience and similar activities. Again, the respective mechanisms are subject to reporting requirements. Be-sides, the AB has to provide information on how it ac-cesses expertise and how this expertise is used in estab-lishing accreditation criteria (see box 4).

Once the NAFP has developed into an independent ac-creditation body and signatory to the IAF / ILAC Arrange-ment, the foreign Partner AB may still be elected by a do-mestic CAB to provide accreditation. In this case, the following steps should be considered by the Partner AB before accepting the application:5 a. Enquire if the applicant is aware of the domestic ac-

creditation bodyb. Suggest that accreditation provided by a domestic ac-

creditation body would better take account of local factors and conditions, where relevant

c. Point out the equivalence of the domestic accredita-tion body’s accreditations as demonstrated through the IAF / ILAC Arrangement

d. Point out that, even if the application is accepted, the local accreditation body may be involved in the accred-itation process

Finally, the cooperation principles under cross frontier accreditation also state that the foreign Partner AB should proceed with the application only if the applicant persists in requiring accreditation by the foreign AB.6

5 ILAC-G21:09/2012 Cross-Frontier Accreditation – Principles for Cooperation, p. 5/6

6 ILAC-G21:09/2012 Cross-Frontier Accreditation – Principles for Cooperation, p. 5

Box 4: IAF/ILAC-A3:01/2013 IAF/ILAC Arrange-ments: Narrative Framework for Reporting on the Performance of an AB – A Tool for the Evaluation Process4.2.6 Access to Expertise for Advising the AB The AB shall describe the mechanism by which it ac-cesses its expertise. (...)The AB shall describe how it identifies the need for technical expertise; how this expertise is recruited, and how it is managed and used in establishing ac-creditation criteria (for both existing and new ac-creditation programs) and advising the AB. The commentary should provide some indication of the expertise available to advise the AB in type, range and volume of the accreditation services offered.


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Part II – Guideline for the establishment of a National Accreditation Focal Point

Each of these four pillars can be sub-divided into differ-ent components. A total of 16 components that the “ar-chitects” of an NAFP need to address are identified in the following scheme (figure 10):

Obviously, the exact shape or relevance of each compon-ent depends on the level achieved or targeted by the NAFP. In the case of a formal Contact Point (Level 1), for instance, component A2, T1 or T4 will only be of minor importance while an independent NAFP Office (Level 5) will have to cover all 16 components to an adequate ex-tent.

Below, examples are provided of what aspects each com-ponent may contain or cover.

5. The components of a National Accreditation Focal Point

A National Accreditation Focal Point is based on four pil-lars that represent the building blocks of any kind of na-tional accreditation structure:

■■ Political Aspects, determining the political and insti-tutional framework in which the NAFP operates

■■ Administration, comprising basic administrative and management-related elements of the NAFP

■■ Technical Aspects, underpinning the technical com-petence of the NAFP related to the accreditation activities it will be involved in

■■ External Relations, relating to marketing and collab-oration arrangements with external stakeholders

National Policy NAFP Office National Expert Pool Stakeholder Network

P1 A1 T1 E1

Governmental Coordination NAFP Manager Quality Management

Competence Awareness Events

P2 A2 T2 E2

Institutional Basis Quality Management System

Comformity Assessment Competence

Recognition by Partner AB

P3 A3 T3 E3

Core Budget Marketing Accreditation Competence

Contract with Partner AB

P4 A4 T4 E4

Political Aspects Administration Technical Aspects External Relations

P A T E

National Accreditation Focal Point

Fig. 10: Components of an NAFP

PA R T I I – G U I D E L I N E F O R T H E E S TA B L I S H M E N T O F A N AT I O N A L A C C R E D I TAT I O N F O C A L P O I N T

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Political Aspects

National PolicyNational quality policy, i.e. regulations on standardiza-tion, metrology, certification, accreditation and quality assurance. National Quality Award. Events such as the World Standards Day, World Metrology Day, World Ac-creditation Day, World Quality Day and World Consumer Day.

Governmental CoordinationCooperation between NAFP and ministries/authorities in sectors relevant for accreditation and conformity assess-ment, e.g. health care, agriculture, industry, trade, SME development, consumer protection, environmental pro-tection, etc. Organization of common events such as public confer-ences, awareness campaigns, etc.

Institutional BasisFormal establishment of the NAFP in an institution in the field of quality infrastructure, in a ministry or another suitable institution (governmental authority, association of industry and trade, chamber of commerce, university, etc.), represented in an organizational chart. Description of the NAFP as an entity.

Core BudgetAppropriate financial and personnel resources to do the work. A budget for communication, office equipment, travel, accommodation, etc. A budget and work plan.

Administration

NAFP OfficeAppropriate office with a postal and email address, tele-communication facilities, office equipment, furniture, re-sponsible officer.

NAFP ManagerOfficial NAFP Manager introduced (Level 2) or trained (Level 3) as a contact person. visits to the Partner AB. Knowledge of all relevant procedures and of the officials of the Partner AB.

Quality Management SystemWork procedures for the handling of requests and applic-ations, for communication with the Partner AB, for in-formation to the clients, for preparation of on-site as-sessments, for handling documents and records, for complaints, for training. Quality Manual against ISO/IEC 17011. Supervision of the implementation of these pro-cedures. Confidentiality commitment.

MarketingInformation material (brochures, leaflets, guides etc.), NAFP web page. Promotion activities (special events).


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Technical Aspects

National Expert PoolIdentification of experts and national centres of expert-ise. Database of experts with a description of the compet-ence profile. Qualification and experience criteria for ex-perts and assessors.

Quality Management CompetenceTrainings on quality management. visits to ISO 9001 cer-tified companies. Experience in auditing.

Conformity Assessment CompetenceTrainings on ISO/IEC 17025 and other conformity assess-ment standards. visits to accredited laboratories, inspec-tion and certification bodies. Experience in conformity as-sessment.

Accreditation CompetenceTrainings on ISO/IEC 17011 and IAF / ILAC Guides. visits to the Partner AB for one week and more (internships). Training and experience in accreditation assessments. Participation in Technical Committee meetings of the Partner AB.

External Relations

Stakeholder NetworkNetworking with representatives of stakeholders. Regular meetings and/or common events with stakeholders. Sup-port of the NAFP work by stakeholders.

Awareness EventsOrganization of event days as the World Standards Day, World Metrology Day, World Accreditation Day, World Quality Day. Public conferences about accreditation and quality assurance.

Recognition by the Partner ABRecognized NAFP experts as qualified assessors. Recog-nized NAFP training activities and resulting certificates.

Contract with the Partner ABMemorandum of Understanding or another contractual document. Annual exchange of experiences about the ac-creditation activities.


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6. Competence of NAFP staff: Recommendations on human resource development

Competence and experience of NAFP staff is a prerequis-ite for the effectiveness and acceptance of an NAFP. Gen-erally speaking, areas of required competence cover qual-ity management, conformity assessment and accreditation. However, the scope and depth of required expertise depends on the respective level of the NAFP (see figure 11).

Competence of NAFPs

Quality Management Conformity Assessment Accreditation Scheme

Level 1:Formal Contact Point

No specific knowledge and experience required



Level 2:CompetentContact person

Introduction (1 day) into ISO 9001, visit of a ISO 9001 certified company

Introduction (1 day) into ISO/IEC 17025 or other related standard, visit of an accredited CAB

Introduction (1 day) into ISO/IEC 17011 and accreditation procedure, visit of the Partner AB

Level 3:Qualified NAFP Manager

Training in ISO 9001 (3 days) and practice as quality manager, internal auditor or ISO 9001 auditor

Training in ISO/IEC 17025 (3 days) or related standard and practice in testing, calibration, inspection or certification activities (> 1 year)

Training in ISO/IEC 17011 (3 days) and practice in accreditation activities by an AB (training on the job, one week and more)

Level 4:NAFP Office (Joint Assessment)


Level 3 plus additional trainings in specific requirements (validation, sampling, traceability, proficiency testing)

Level 3 plus additional trainings in assessment of CABs (training on the job depending on AB policies)

Level 5:Independent NAFP Office (Joint Accreditation)


Level 4 plus additional experience in specific requirements (validation, sampling, traceability, proficiency testing)

Level 4 plus appropriate experience in assessment of CABs (training on the job depending on AB policies)

Fig. 11: Areas and examples of required competence of NAFP staff


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Solid knowledge and competence is especially needed for staff which is significantly involved in the accreditation procedure, i.e. staff in NAFP at Level 3 and beyond. They shall be competent in theory (by trainings) and practice (by experience) in the three mentioned areas. The main standards, which should be well known, are:

■■ in Quality Management: ISO 9001 (quality manage-ment), ISO 19011 (auditing), and audit aspects of APG-Guidelines of ISO and IAF7,

■■ in Conformity Assessment: ISO/IEC 17025 (laborat-ories), ISO 15189 (medical laboratories), ISO/IEC 17020 (inspection bodies), ISO/IEC 17021 (certifica-tion bodies for management systems), ISO/IEC 17024 (certification bodies for personnel), ISO/IEC 17065 (certification bodies for products, processes and services),

■■ in Accreditation: ISO/IEC 17011 (accreditation), AAPG-Guidelines of ISO and IAF8 and their related ILAC and IAF documents.

The Partner AB has policies for competence and training of all persons who are involved in accreditation activities. The NAFP staff should be integrated into the training programs and plans of the Partner AB to ensure compet-ence and continual improvement. This is also required ac-cording to IAF / ILAC guidelines (see chapter 4).

7 Auditing Practices Group Guidelines; see http://www.iaf.nu/articles/ISO_9001_Auditing_Practices_Group/37

8 Accreditation Auditing Practice Guidelines, see http://isotc.iso.org/livelink/livelink?func=ll&objId=4298140&objAction=browse&sort=name

7. The roadmap to establish a National Accreditation Focal Point

Before starting to prepare the establishment of an NAFP, an initial needs assessment should be conducted. This as-sessment should cover the estimated number of poten-tial customers and their main fields of activities, the exist-ing stakeholder network and the broad policy framework. In addition, a rough estimation of the required infrastruc-ture and human resources may help to inform and con-vince political decision-makers about the scope of the needed investment.

In case accreditation activities start from scratch, the ini-tial assessment may comprise the following aspects:

NAFP infrastructure & staffing■■ Which institution shall be hosting the NAFP?■■ Has/Have any person(s) already been selected as re-

sponsible NAFP “contact point”? If yes: To what ex-tent have these persons already gained knowledge and received training in the field of accreditation / conformity assessment / quality management?

■■ Will the responsible contact point have an appropri-ate office, including telecommunication capabilities?

Policy framework■■ Do a national quality policy, sector-specific regula-

tions or trade agreements exist which include re-quirements related to accreditation and conformity assessment?

■■ Does a cooperation exist between the institution hosting the NAFP and (other) ministries with a pos-sible stake in accreditation matters (e.g. in the health care, trade & exports sector)?

■■ Has any draft strategy to facilitate accreditation ser-vices in the country already been developed?


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Partnerships and stakeholder network■■ Has the (future) NAFP access to national experts

which are familiar with accreditation / conformity as-sessment?

■■ Does the (future) NAFP have regular contact with ac-creditation stakeholders from the private and public sector (e.g. testing laboratories, Chamber of Com-merce, national calibration laboratory)?

■■ Does the institution hosting the (future) NAFP ar-range or participate in public conferences or promo-tional activities in the field of quality / conformity as-sessment?

Potential customers■■ What is the estimated number of conformity assess-

ment bodies (CABs) operating in the country that are preparing / potentially looking for accreditation?

■■ What fields do these CABs cover (testing, calibration, inspection, certification)?

■■ Is there any information material on accreditation available for potential clients interested in accredita-tion?

For a more detailed self-assessment, a checklist is provided in annex 2.

Once the needs assessment is completed, steps to estab-lish the NAFP should be prepared. This establishment is – in an ideal case – based on the 16 components de-scribed in chapter 5 and should follow a certain sequence. This sequence is outlined in figure 12 and represents a roadmap to implementing the NAFP concept.

Some recommended activities with respect to selected components are listed below:

Political Aspects

National Policy

National Coordination

Institutional Basis

Core Budget

Administation NAFP Office NAFP Manager

Quality Management

System

Marketing/ Public

Relations

Technical Aspects

National Expert Pool

Q- Management Competence

Conf. Assment Competence

Accreditation Competence

External Relations

Stakeholder Network

Awareness Events

Recognition by PAB

NAFP Contract with PAB

P2

A2

T2T2

E2

P3

A3

T3

E3

P4

A4

T4

E4

E4

P1

A1

Fig. 12: Roadmap for the establishment of an NAFP


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National Policy: Facilitate the formulation of a national quality policy by the responsible or coordinating ministry, consistent with industry and trade policies. Decide on the status of the NAFP by law, governmental decree and stat-utes with a clear agreement with the government that it is recognized as a National Accreditation Focal Point.

Institutional Basis: Decide on the type of legal identity of the NAFP and the connection to an institution. Avoid po-tential conflicts of interest to related bodies.

NAFP Manager: Create a clear management structure, organizational chart and job descriptions. Appoint secret-arial staff, if necessary.

Quality Management System: Develop the necessary quality manual and major procedures required for the NAFP and the activities it will be performing.

National Expert Pool: Identify experts in national centres of expertise. Describe their competence profiles via Part-ner AB questionnaires and checklists. Work with the Part-ner AB to train and qualify the experts to be able to parti-cipate in the accreditation assessment activities.

Stakeholder Network: Create a network composed of stakeholders, including representatives from industry, trade, universities, associations, laboratory networks, in-spection and certification bodies, consumer organiza-tions, relevant ministries etc. Participate in their events and present the QI system and the NAFP services.

Recognition by Partner AB: Coordinate the development of quality documents with the Partner AB. Present the national experts to be acknowledged and qualified as as-sessors. Assure that all training activities and certificates of qualification are recognized by the Partner AB.

NAFP Contract with Partner AB: Develop and sign a Memorandum of Understanding or another contractual document with the Partner AB. Organize or participate in annual exchanges of experiences.


21

In the case of an advanced NAFP at level 4 or 5, the 16 components can be visualized as bricks of a “House of a National Accreditation Focal Point” (see figure 13). The four pillars represent the political, administrative, tech-nical and external relations aspects presented in chapter 5; the basement is built by the “National Policy”. The roof represents the final result: Internationally recognized ac-creditation services facilitated by the NAFP, based on a contract or arrangement with a Partner Accreditation Body.

Ideally, the way of establishing an NAFP should follow the same logic as when constructing a real house: Start with the basement, continue from bottom to top, end with the roof and be aware of the statics. In practice, however, work on the NAFP House could start at any point where resources are available.

Core Budget

Institututional Basis

National Coordination

National Policy

Marketing

Quality Management System

NAFP Manager

NAFP Office

Accreditation Competence

Conformity Assessment Competence

Quality Management Competence

National Expert Pool

Recognition by Partner Accreditation Body

Awareness Events

Stakeholder Network

Contract with Partner Accreditation Body

NAFP Region

Internationally recognized accreditation facilitated by the NAFP

P4

P3

P2

P1

A4

A3

A2

A1

T4

T3

T2

T1

E3

E2

E1

E4

Fig. 13: The „NAFP House“


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8. Conclusions and outlook

During the last decade, NAFPs have been emerging under different names around the globe and developed into an integral part of regional integration schemes. Increasing requirements to demonstrate competence of conformity assessment bodies in areas such as food, environment and health suggest that partnerships and regional collab-oration arrangements will continue to grow in the future. This applies in particular to developing countries that – despite limited markets and scarce resources – seek to rapidly establish internationally recognised accreditation services for industry and government.

Despite empirical evidence on this general trend towards sharing of accreditation facilities, there is no blueprint on how NAFPs should exactly operate or how they should be set up. Instead, a range of options exists, depending on the political and institutional environment, market de-mand or preferences and comparative advantages of the Partner AB. Therefore, the levels and steps from an emer-ging towards a fully developed NAFP are not necessarily stages of a linear development process but rather pos-sible cooperation models which could all be established in their own right. The choice of the appropriate model depends, among others, on the available resources, the historical evolution of the national quality infrastructure and economic policy objectives.

What appears crucial for the functioning of an NAFP is that expectations, roles and responsibilities of the in-volved parties are clarified from the outset and that top management is committed to practically implement the agreed modes of partnership. Another success factor is a sensitized and supportive stakeholder community, in-cluding economic and political decision makers. Particu-larly the latter may regard the term “NAFP” as pejorative so that awareness-raising on the concept, advantages but also challenges is essential in order to gain political sup-port.

Regardless of how fast and up to what level the NAFP in a specific country is actually developing, it should be kept in mind that accreditation is closely linked with other components of the national quality infrastructure. Thus, substantial and sustainable progress in developing ac-creditation facilities could only be achieved if, in parallel, the whole QI system is developing, including an effective market-surveillance. In this context, collaborative ap-proaches to capacity building – as applied in the case of NAFP – could also be transferred to other areas of QI, for instance, to share sophisticated testing and calibration fa-cilities.

Last, it should be noted that despite the global prolifera-tion of NAFPs, the concept hasn’t received full attention by the regional and international accreditation networks, yet. In fact, NAFPs seem still to be predominately re-garded as informal mechanism of cross frontier accredit-ation while a discussion on the possible membership status of these bodies and their integration into formal network structures has only recently started with respect to the activities of SADCAS and its NAFPs. It can be hoped that this discussion will contribute to highlight the particular needs of developing economies so that, ulti-mately, NAFPs will be become a recognized player in pur-suit of the motto: Tested / certified once, accepted every-where.

A N N E x 1

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Annex 1

Memorandum of Understanding between an NAFP and a Partner Accreditation Body (draft model)9

Introduction

Together with standardisation and metrology, accredita-tion represents a key pillar of the national quality infra-structure. Such a quality infrastructure is important to re-duce technical barriers to trade and, ultimately, to facilitate regional and global economic integration. Ac-creditation is therefore one of the tools recommended by WTO as well as by regional trade agreements in order to overcome trade barriers by establishing equivalence of test results and certification.

Recognising the crucial contribution accreditation can play in this context, a National Accreditation Focal Point (NAFP) is in progress to be established in country ____________. Its core function is to facilitate the provision of internationally recognised accreditation services in the field of conformity assessment. To support the NAFP in this endeavour, the following partnership agreement has been signed between ________ (NAFP) and ________ (PAB).

9 With reference to the model developed by Mr Hanspeter Ischi

Purpose of the agreement

The purpose of the cooperation is to provide accredita-tion services by the PAB to conformity assessment bodies in the country and, in parallel, to support the further de-velopment of the NAFP.

Technical Assistance

With a view to facilitating the effective attainment of the above purpose, technical assistance will be provided by the PAB through the following indicative activities:■■ provide the necessary guidance and training to NAFP

staff on requirements for accreditation,■■ provide the necessary information and documents re-

quired for submitting applications to PAB,■■ perform assessments in cooperation with the NAFP

according to the NAFP level reached,■■ invite NAFP staff to visit PAB to observe its opera-

tions and assessments; in turn, PAB staff will be in-vited to visit the NAFP to supervise and guide the op-erations, if necessary,

■■ support the development of information material such as brochures or leaflets about the NAFP, its role, twinning arrangement and services being offered in the country,

■■ participate in awareness programs as mutually agreed by both sides.

A N N E x 1

24

Financial Provisions

All financial obligations resulting from this cooperation will have to be met by the NAFP and will be subject to prior agreement.

All expenses related to assessment and accreditation of CAB’s will be as per agreed fee structure and will be borne by applicant CAB’s.

Monitoring

The NAFP will invite the PAB to monitor its development and to conduct internal audits at the NAFP in order to es-tablish trust and understanding in both organisations.

Further Provisions

Accreditation to CAB’s in the country will be granted by PAB after successful completion of the (joint) assess-ments. NAFP and PAB will develop a certificate, which should reflect the partnership of the two bodies and which is conforming to the ISO/IEC 17011 standard as well as to the ILAC/IAF criteria.

Accredited CAB’s have to comply with the criteria and Terms & Conditions for maintaining PAB accreditation and will be allowed to bear both accreditation logos, that of PAB and that of NAFP.

PAB will conduct regular surveillance and reassessment of the accredited CAB’s in the country. Surveillance visits and re-assessments will be done jointly.

Contacts

Any communication with respect to this MoU shall be submitted to the following contact addresses:For the NAFP: _________For the PAB: _________

Settlement of Disputes

Any dispute arising out of or in connection to this MoU shall be resolved amicably and in good faith by direct consultations between both parties.

A N N E x 1

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Annex 2

Lead questions for self-assessment

National Policy■■ Is the NAFP laid down in a legislative act? ■■ Does a national quality policy exist? ■■ Are there regulations regarding standardization, met-

rology, certification, accreditation, quality assurance? ■■ Does a National Quality Award exist? ■■ Are public events celebrated, such as the

World Standards Day, World Metrology Day, World Accreditation Day, and/or World Quality Day

Governmental Coordination■■ Do the NAFP and the responsible ministries and au-

thorities cooperate in the sector of health, agricul-ture, industry, trade, SME development, consumer protection, environmental protection, tourism, con-struction, energy, etc?

■■ Are all relevant contact persons identified? ■■ Are any common events arranged as public confer-

ences, awareness campaigns?

Institutional Basis■■ Has the NAFP formally been established in

an institution of metrology, standardization, tes-ting, inspection, certification, quality assurance,

a ministry or other governmental authority, an association of industry and trade, a chamber of trade and commerce, a university or any other institution? ■■ Is it represented in an organizational chart? ■■ Is there a clear description of the NAFP as an entity?

Core Budget■■ Does the NAFP have appropriate financial and hu-

man resources to accomplish the work? ■■ Are the costs covered, e.g. for

communication (telephone, fax, IT), other office equipment (copy machine, projector), facilities, travel, accommodation, etc.■■ Is there a budget plan?

NAFP Office■■ Does the NAFP have an appropriate office with

a responsible officer an address, an email account, telecommunication equipment, office equipment, furniture, etc.?

NAFP Manager■■ Does the NAFP have a designated official NAFP Man-

ager as contact person (Level 2)? ■■ Is the person introduced to (Level 2) or trained (Level

3) by the Partner Accreditation Body? ■■ Has the Manager visited the Partner AB? ■■ Does he know all relevant procedures and officials of

the Partner AB?

Quality Management System■■ Has the NAFP established work procedures

for the handling of requests and applications, for the communication with the Partner AB, for information to the clients, for preparation of on-site assessments, for handling documents and records, for complaints and appeals, for training? ■■ Are these procedures integrated in a Quality Manual? ■■ Is the implementation of these procedures super-

vised? ■■ Have all relevant persons signed a confidentiality

commitment?

Marketing■■ Is there information material (brochures, leaflets,

guides, etc.) for interested clients? ■■ Has an NAFP webpage been established? ■■ Does the NAFP implement promotional activities

(special events) to inform the public about national accreditation services?

A N N E x 2

26

National Expert Pool■■ Has the NAFP identified any national centres of ex-

pertise? ■■ Does a database of experts with a description of the

competence profile exist? ■■ Are these experts presented to the Partner AB to be

integrated into assessment activities?

Quality Management Competence■■ Has the NAFP Manager participated in training on

ISO 9001 and ISO 19011? ■■ Has the NAFP Manager visited ISO 9001 certified

companies? ■■ Does the NAFP Manager have training and experi-

ence in auditing?

Conformity Assessment Competence■■ Has the NAFP Manager participated in training on

ISO/IEC 17025 and other conformity assessment standards?

■■ Has the NAFP Manager visited accredited laborator-ies, inspection and certification bodies?

■■ Does the NAFP Manager have training and experi-ence in conformity assessment?

Accreditation Competence■■ Has the NAFP Manager participated in training on

ISO/IEC 17011 and ILAC / IAF Guides? ■■ Has the NAFP Manager visited the Partner AB for one

week and more? ■■ Does the NAFP Manager have training and experi-

ence in accreditation assessments?

Stakeholder Network■■ Is the NAFP well-informed about the relevant stake-

holders? ■■ Are stakeholders informed about the NAFP’s activit-

ies? ■■ Is there a regular meeting and/or common events

with stakeholders? ■■ Do the stakeholders support the NAFP’s work?

Awareness Events ■■ Is the NAFP itself involved in event days as the

World Standards Day, World Metrology Day, World Accreditation Day, World Quality Day? ■■ Does the NAFP arrange or participate in public con-

ferences about accreditation and quality assurance?

Recognition by Partner AB■■ Do all work procedures of the NAFP comply with the

regulations of the Partner AB? ■■ Are the technical experts of the NAFP acknowledged

as qualified assessors? ■■ Are NAFP training activities and resulting certificates

acknowledged by the Partner AB? ■■ Will the NAFP be informed about regional and inter-

national activities in accreditation schemes (ILAC, IAF, ISO, etc)?

Contract with Partner AB■■ Has the NAFP signed a Memorandum of Understand-

ing or another contractual document with the Part-ner AB, which settles all aspects of the cooperation?

■■ Is there an annual exchange of experiences related to the accreditation activities?

A N N E x 2

27

ImprintPublished byPhysikalisch-Technische BundesanstaltBundesallee 10038116 BraunschweigGermany

ResponsibleDr. Marion StoldtPhone +49 531 592-82 00Fax +49 531 592-82 25E-Mail [email protected]/q5

TextManfred KindlerUwe Miesner

GraphicsPhysikalisch-Technische Bundesanstalt

As of July 2015

28

I M P R I N T

ContactPhysikalisch-Technische BundesanstaltTechnical CooperationUwe MiesnerTel +49 531 592 8220Fax +49 531 592 [email protected]/q5

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